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NCT Number: NCT07557316

Nodal Downstaging Versus Primary Tumor Regression as Predictors of Survival After Total Neoadjuvant Therapy for Rectal Cancer: A Retrospective Study

To evaluate the prognostic impact of post-TNT pathological nodal status (ypN) on LRFS, DMFS, and OS, and compare it with that of primary tumor response

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University

Sohag, Egypt

About this study

Disease-free survival (DFS), measured from surgery to recurrence (local or distant) or death. DFS will be evaluated in correlation with the pathological response after TNT, comparing the prognostic impact of nodal status (ypN0 vs ypN+) and primary tumor response (ypT stage and/or tumor regression grade).

  • overall survival (OS), defined as the time from the date of diagnosis to death from any cause, and will be analyzed in the same manner as DFS in correlation with the pathological nodal status and primary tumor response.
  • Identification of Independent Prognostic Factors: To identify which clinical and pathological factors independently affect disease-free and overall survival after adjusting for other variables.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients who were more than18 years old at time of diagnosis. Pathological confirmation of rectal adenocarcinoma. Locally advanced stage II&III rectal carcinoma (≥T3 and or N+) at initial diagnosis.

Patients treated with Total Neoadjuvant Therapy (TNT), including either chemoradiotherapy (CRT) followed by consolidation chemotherapy, induction chemotherapy followed by CRT, or short-course radiotherapy (SCRT) followed by chemotherapy, and subsequently undergoing TME.

Available pathological assessment of surgical specimens.

Exclusion criteria

Patients with distant metastasis at presentation or other comorbid diseases. Patients with incomplete clinical and pathological staging information. Missing key clinical or pathological data. Patients who did not receive TNT or undergo TME surgery.

Treatment and study plan

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: 1 year

    Disease-free survival (DFS), measured from surgery to recurrence (local or distant) or death. DFS will be evaluated in correlation with the pathological response after TNT, comparing the prognostic impact of nodal status (ypN0 vs ypN+) and primary tumor response (ypT stage and/or tumor regression grade).

Secondary outcomes

  1. overall survival (OS)

    Time frame: 1 year

    • overall survival (OS), defined as the time from the date of diagnosis to death from any cause, and will be analyzed in the same manner as DFS in correlation with the pathological nodal status and primary tumor response.
    • Identification of Independent Prognostic Factors: To identify which clinical and pathological factors independently affect disease-free and overall survival after adjusting for other variables

Study contacts

Contact information is provided by the study sponsor or research team.

Manar Abd El-Mawla Mohamed, master

CONTACT

[email protected]

01114314946 ext. 002

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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